Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Maximum pain
研究概览
简要总结
The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.
详细描述
A prospective randomized open clinical trial conducted in two high volume emergency departments in France.
Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method.
126 patients are expected to enrol in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Superficial skin laceration requiring a suture
排除标准
- •Known allergy to lidocaine
- •Mucous membrane or eye wound
- •Nose, ear or perineal wound
- •Active hemorrhage in the wound
- •Dirty or infected wound
- •Wound requiring operation room management
- •Distracting pain in an other location
- •Intoxicated or comatose patient
- •Patient Under guardianship
- •Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia
- •Neurologic disorder affecting pain sensitivity
- •Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age
- •Absence of signed informed consent
- •Inclusion in an other interventional clinical protocol
研究组 & 干预措施
Topical anesthesia
Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.
干预措施: Lidocaine-Prilocaine Cream 2.5-2.5% (Drug)
Subcutaneous injection anesthesia
Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.
干预措施: Lidocaine 1% Epinephrine 0.005mg/mL solution (Drug)
结局指标
主要结局
Maximum pain
时间窗: 60 minutes
Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).
次要结局
- Patient satisfaction(60 minutes)
- Management duration(60 minutes)
- Wound healing(15 days)
- Pain management during the various stages of care(60 minutes)
- Topical anesthesia failure rate(60 minutes)
- Adverse effects(15 days)